Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.

Liver Cirrhosis Clinical Trial

Official title:

Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03995251
• Other study ID #: ILBS-Cirrhosis-21
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Shushrut Singh, MD
• Phone: 01146300000
• Email: drsushrut20[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Study Population- Patient with cirrhosis with any aetiology with sarcopenia visiting ILBS OPD/IPDs who are willing to visit ILBS gymnasium twice weekly for first month.

• Study Design- A Prospective Randomized Controlled Trial

• Study Period- Study will be conducted at ILBS from April 2019 to Oct 2019

• Sample Size:As shown by Eva Roman et al - in cirhotics with sarcopenia exercise increases mean lean appendicular mass , by 0.38 kg (14 patients, p < 0.03), and Sinclair et al has shown testosterone (22 patients, p <0.05)) to increase mean Appendicular lean mass by +1.69 kg - for 10% increase in APLM

• we need to enroll 40 patients in each arm, and considering a los to follow up approx.10% , will require minimum 44 patients in each arm

• We will therefore enroll and randomize 100 patients with 50 in each arm.

Intervention - Testosterone Supplementation - Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations.

Monitoring and assessment - On every visit patient will be inquired or evaluated for side effects like local site pain or hematoma , hypertension, headache, allergic reactions, acne, nausea , mood swings, pedal edema , breast enlargement and others.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Men with cirrhosis of any etiology

• Sarcopenia

• CTP 6-12

Exclusion Criteria:

• Hepatocellular carcinoma

• Other known malignancy,

• CTP > 12

• Acute liver injury

• Prostate disease,

• Known hypersensitivity to testosterone therapy,

• Polycythaemia (haematocrit >55%),

• Uncontrolled hypertension (>160/90 mmHg despite treatment),

• Uncontrolled obstructive sleep apnoea,

• Severe renal dysfunction (estimated glomerular filtration rate <30ml/min)

• Uncontrolled epilepsy, migraine, or significant cardiac insufficiency (New York Heart Association class III or IV or LVEF < 45-50%.

• CKD (Chronic Kidney Disease) - eGFR (Glomerular Filtration Rate) <60%

• Platelet count below 30,000 or taking warfarin

• Failure to give consent.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Sarcopenia

Intervention

Drug:
• Testosterone Supplementation
Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations
• Standard Medical Treatment
Standard Medical Treatment

Other:
• Exercise
Exercise

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Lean Appendicular Muscle Mass by more than 10% in both groups		24 weeks
Secondary	Improvement by 10 % in Hand Grip strength in both groups		24 weeks
Secondary	Improvement by 10 % in6 minute walk distance in both groups		24 weeks
Secondary	Improvement by 10 % in the increased bone and muscle mass in both groups		24 weeks
Secondary	Improvement by 10 % L3 Skeletal Muscle Index in both groups.		24 weeks
Secondary	Improvement by 10 % in serum ammonia levels in both groups		24 weeks
Secondary	Improvement by 10 % in muscle fibres on Biopsy in both groups •		24 weeks
Secondary	Reduction in Myostatin level in both groups		24 weeks
Secondary	Improvement in MELD scores in both groups		24 weeks
Secondary	Decrease in mortality over 6 months in both groups		24 weeks
Secondary	Changes in HBA1C level in both groups		24 weeks
Secondary	Reduction in requirement of hospital admissions in both groups		24 weeks
Secondary	Decrease in TNF alpha levels in both groups		24 weeks